Drug recall D-1413-2014
Product
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Reason for recall
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Lots and codes
Lot #: C926923, Exp 01/16
Recall details
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
- Quantity
- 20,810 containers
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 16, 2014
- Terminated
- April 10, 2017
Related products
- Brevibloc – drug information
- NDC 10019-115 Brevibloc · Esmolol Hydrochloride 10 mg/mL · Baxter Healthcare Company
- NDC 10019-055 Brevibloc · Esmolol Hydrochloride 10 mg/mL · Baxter Healthcare Company
- NDC 10019-075 Brevibloc · Esmolol Hydrochloride 20 mg/mL · Baxter Healthcare Company